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ASCO 2022: Pathologic Regression and Event-Free Survival With Nivolumab Plus Chemotherapy for NSCLC

By: Julia Fiederlein
Posted: Monday, June 13, 2022

In the phase III CheckMate 816 trial, patients with resectable non–small cell lung cancer (NSCLC) who were treated with neoadjuvant nivolumab plus chemotherapy experienced significant and clinically meaningful improvements in event-free survival and pathologic complete response compared with those who received chemotherapy alone, according to Mariano Provencio-Pulla, MD, PhD, of the Hospital Universitario Puerta de Hierro, Madrid, and colleagues. The results of a post hoc analysis, which were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8511), characterized the association between pathologic regression and event-free survival in this population.

“Pathologic response in the primary tumor was associated with improved event-free survival with neoadjuvant nivolumab plus chemotherapy,” the investigators remarked. “Additionally, [the] depth of pathologic regression appeared to be predictive of improved event-free survival.”

Adults with stage IB to IIIA disease were randomly assigned to receive three cycles of platinum-doublet chemotherapy once every 3 weeks with (n = 141) or without (n = 126) 360 mg of nivolumab. At a minimum follow-up of 21 months, the median durations of event-free survival were prolonged in patients from both treatment arms who achieved a pathologic complete response (nivolumab plus chemotherapy: not reached vs. 27.8 months; chemotherapy alone: not reached vs. 26.2 months) or a major pathologic response (nivolumab plus chemotherapy: not reached vs. 25.1 months; chemotherapy alone: not reached vs. 24.9 months), compared with the nonresponders.  

At 2 years, the percentage of residual viable tumor seemed to be predictive of event-free survival with nivolumab plus chemotherapy (AUC = 0.74)—but not with chemotherapy alone (AUC = 0.54). The 2-year rates of event-free survival with nivolumab plus chemotherapy were 90%, 60%, 57%, and 39% in patients with 0% to 5%, between 5% and 30%, between 30% and 80%, and more than 80% residual viable tumor, respectively.

Disclosure: For full disclosures of the study authors, visit

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